510(k) K180548 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology
| Applicant | C.R. Bard, Inc (Bard Has Joined Bd), Salt Lake Ciy, UT, US |
| Decision | Substantially Equivalent, Apr 26, 2018 |
| Received | Mar 1, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180548
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2026 | Bard Access Systems, Inc. CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen
UDI-DI Code: 00801741236129
CK000883 PowerPICC Provena Catheter 4 Fr Dual-Lumen
UDI-DI Code: 00801741188800
CK000884A PowerPICC Provena SOLO Open, Classified |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.